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16 June 2022Big PharmaSarah Speight

Glycosyn sues Abbott over infant formula method

Biotech company Glycosyn has sued Abbott Laboratories for allegedly infringing its patented method for manufacturing a key ingredient in infant formula milk, found in three of Abbott’s infant formula products under the Similac brand.

Glycosyn accuses Abbott of using its “novel” method to make the complex sugar molecule, made from human milk oligosaccharides (HMOs), via supplier Jennewein Biotechnologie—acquired by Chr. Hansen in 2020 to lead the HMO market.

The predominant HMO molecule found in human milk, and one of the most studied from an infant health perspective, is known as 2′-fucosyllactose (“2′-FL”), as detailed by the court complaint, filed on June 14 at the US District Court for the Western District of Texas (Waco) and presided over by Judge Albright.

Glycosyn argues that it has researched, developed and sold products based on HMOs and, due to their benefits to gut health, especially in infants, makers of infant formula have looked to use them in various products.

2′-FL consists of a lactose molecule (known as ‘milk sugar’) fused to another sugar molecule known as fucose.

“Owing to its chemical complexity, 2′-FL is difficult to make in large quantities in the laboratory via traditional chemical synthesis”, states the complaint. “To solve this problem, Glycosyn developed novel methods for making large quantities of 2′-FL by harnessing the power of genetic engineering.”

Glycosyn claims that Abbott developed methods of genetically engineering E. coli to make large amounts of pure 2′-FL.

This solution to making 2′-FL, argues the plaintiff, was successful, and other manufacturers have used the same method.

Abbott worked closely with Jennewein, which “knowingly used Glycosyn’s patented methods to make 2′-FL in Europe, which Jennewein subsequently imported into the US and sold to Abbott for use in various Abbott products”, alleges Glycosyn.

The products in question are Similac Pro-Advance, Similac Pro-Sensitive, and Similac Pro-Total Comfort, and have been sold via online retailers such as Walmart, Target, and Amazon.

Exclusion order

Previously, Glycosyn sued Jennewein via the International Trade Commission (ITC) for the illegal importation of 2′-FL, made in certain E. Coli bacterial strains, which was decided on May 19, 2020. The ITC subsequently issued a Limited Exclusion Order against Jennewein for making 2′-FL via these strains.

This exclusion order, the plaintiff states, is unrelated to the current shortage of infant formula in the US.

The period of alleged infringement of the patent (US No. 9,970,018) is between May 15, 2018 (when the patent was issued) to May 19, 2020 (when the ITC issued the exclusion order against Jennewein).

Abbott’s infringement, claims Glycosyn, was “wilful”, having received a cease-and-desist letter from the plaintiff dated October 4, 2018.

A subpoena was then issued to Abbott on October 11, 2018, regarding Glycosyn’s ITC action against Jennewein, asserting the ’018 patent.

Glycosyn issued a second cease-and-desist letter on October 4, 2019, to inform Abbott of an Initial Determination by ITC, finding that the 2ʹ-FL used in the products in question are manufactured using methods that infringe Glycosyn’s patent.

LSIPR has contacted both parties for comment.

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